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A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course

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ClinicalTrials.gov Identifier: NCT00988052
Recruitment Status : Terminated (Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.)
First Posted : October 1, 2009
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing Multiple Sclerosis
Intervention Drug: Laquinimod
Enrollment 839
Recruitment Details In the preceding double-blind, placebo-controlled ALLEGRO study (study MS-LAQ-301), 1106 subjects with RRMS were randomized to treatment, and 864 subjects completed the study according to the protocol (ie, by completing the ALLEGRO study termination visit procedures).
Pre-assignment Details In this open-label extension study, 839 subjects with RRMS were enrolled to receive laquinimod 0.6 mg at 135 study sites in 22 countries by 135 investigators.
Arm/Group Title Early Laquinimod Switch From Placebo
Hide Arm/Group Description

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Period Title: Overall Study
Started 423 416
Completed 0 0
Not Completed 423 416
Reason Not Completed
Missing             1             0
Teva requested subject withdrawal             3             1
Death             1             3
Protocol Violation             6             5
Pregnancy             6             6
Lack of Efficacy             8             7
Lost to Follow-up             6             11
Physician Decision             27             28
Adverse Event             35             28
Withdrawal by Subject             90             91
Study terminated by sponsor             240             236
Arm/Group Title Early Laquinimod Switch From Placebo Total
Hide Arm/Group Description

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Total of all reporting groups
Overall Number of Baseline Participants 423 416 839
Hide Baseline Analysis Population Description
Participants enrolled in the MS-LAQ-301 extension study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 423 participants 416 participants 839 participants
41.1  (9.10) 40.5  (9.14) 40.8  (9.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 423 participants 416 participants 839 participants
Female
298
  70.4%
271
  65.1%
569
  67.8%
Male
125
  29.6%
145
  34.9%
270
  32.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 423 participants 416 participants 839 participants
Asian / Oriental
2
   0.5%
0
   0.0%
2
   0.2%
Black / African American
1
   0.2%
5
   1.2%
6
   0.7%
Caucasian
414
  97.9%
401
  96.4%
815
  97.1%
Other
2
   0.5%
2
   0.5%
4
   0.5%
Missing
1
   0.2%
2
   0.5%
3
   0.4%
Unknown
3
   0.7%
6
   1.4%
9
   1.1%
1.Primary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.
Time Frame Day 1 up to 7.64 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Early Laquinimod Switch From Placebo
Hide Arm/Group Description:

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Overall Number of Participants Analyzed 423 416
Measure Type: Count of Participants
Unit of Measure: Participants
=>1 TEAE
375
  88.7%
374
  89.9%
=>1 Severe TEAE
76
  18.0%
69
  16.6%
=>1 TEAE of special interest
109
  25.8%
105
  25.2%
=>1 treatment-related TEAE
139
  32.9%
153
  36.8%
=>1 TEAE leading to death
3
   0.7%
3
   0.7%
=>1 Serious TEAE
108
  25.5%
92
  22.1%
=>1 TEAE causing discontinuation
35
   8.3%
32
   7.7%
2.Secondary Outcome
Title Participants With Potentially Clinically Significant Abnormal Vital Signs
Hide Description

Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria:

  • Pulse rate low: <=45 and decrease >=30 beats/minute
  • Pulse rate high: >=120 and increase >=30 beats/minute
  • Systolic blood pressure low: <=90 and decrease >=30 mmHg
  • Systolic blood pressure high: >=180 and increase >=30 mmHg
  • Diastolic blood pressure low: <=50 and decrease >=20 mmHg
  • Diastolic blood pressure high: >=100 and increase >=20 mmHg
Time Frame Day 1 up to 7.64 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with a baseline and post-baseline value for that vital sign.
Arm/Group Title Early Laquinimod Switch From Placebo
Hide Arm/Group Description:

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Overall Number of Participants Analyzed 423 416
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with at least one abnormality
36
   8.5%
34
   8.2%
Pulse rate - low
1
   0.2%
1
   0.2%
Pulse rate - high
2
   0.5%
1
   0.2%
Systolic blood pressure - low
20
   4.7%
10
   2.4%
Systolic blood pressure - high
1
   0.2%
2
   0.5%
Diastolic blood pressure - low
7
   1.7%
7
   1.7%
Diastolic blood pressure - high
8
   1.9%
14
   3.4%
3.Secondary Outcome
Title Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Hide Description

Counts include two conditions:

  • a change from High / Non-PCS at baseline to Low PCS at any point during the study
  • a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non- PCS value are included in the population count. ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium
Time Frame Day 1 up to 7.64 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with both a baseline and a post-baseline value for the test.
Arm/Group Title Early Laquinimod Switch From Placebo
Hide Arm/Group Description:

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Overall Number of Participants Analyzed 422 415
Measure Type: Count of Participants
Unit of Measure: Participants
ALT - change from Low / Non- PCS to High PCS
8
   1.9%
14
   3.4%
Albumen - change from High / Non-PCS to Low PCS
1
   0.2%
0
   0.0%
ALP - change from Low / Non- PCS to High PCS
3
   0.7%
0
   0.0%
p-Amylase - change from Low / Non-PCS to High PCS
2
   0.5%
6
   1.4%
AST - change from Low / Non- PCS to High PCS
4
   0.9%
5
   1.2%
CRP - change from Low / Non- PCS to High PCS
41
   9.7%
51
  12.3%
Calcium - change from High / Non-PCS to Low PCS
1
   0.2%
4
   1.0%
Calcium - change from Low / Non-PCS to High PCS
1
   0.2%
2
   0.5%
CK - change from Low / Non- PCS to High PCS
16
   3.8%
17
   4.1%
CTN - change from Low / Non- PCS to High PCS
2
   0.5%
2
   0.5%
FIB - change from Low / Non- PCS to High PCS
37
   8.8%
38
   9.2%
GGT - change from Low / Non- PCS to High PCS
33
   7.8%
24
   5.8%
Glucose - change from High / Non-PCS to Low PCS
23
   5.5%
27
   6.5%
Glucose - change from Low / Non-PCS to High PCS
9
   2.1%
5
   1.2%
Phosphate-change from High / Non-PCS to Low PCS
14
   3.3%
15
   3.6%
Phosphate-change from Low / Non-PCS to High PCS
19
   4.5%
16
   3.9%
K - change from High / Non- PCS to Low PCS
4
   0.9%
3
   0.7%
K - change from Low / Non- PCS to High PCS
46
  10.9%
55
  13.3%
Sodium - change from High / Non-PCS to Low PCS
8
   1.9%
3
   0.7%
Sodium - change from Low / Non-PCS to High PCS
13
   3.1%
17
   4.1%
Urea - change from Low / Non- PCS to High PCS
3
   0.7%
4
   1.0%
4.Secondary Outcome
Title Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Hide Description

Counts include two conditions:

  • a change from High / Non-PCS at baseline to Low PCS at any point during the study
  • a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non- PCS value are included in the population count.
Time Frame Day 1 up to 7.64 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with both a baseline and a post-baseline value for the test.
Arm/Group Title Early Laquinimod Switch From Placebo
Hide Arm/Group Description:

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Overall Number of Participants Analyzed 422 415
Measure Type: Count of Participants
Unit of Measure: Participants
Hematocrit - change from High / Non-PCS to Low PCS
36
   8.5%
29
   7.0%
Hemoglobin -change from High / Non-PCS to Low PCS
27
   6.4%
22
   5.3%
Hemoglobin -change from Low / Non-PCS to High PCS
0
   0.0%
1
   0.2%
Leukocytes - change from High / Non-PCS to Low PCS
1
   0.2%
1
   0.2%
Leukocytes - change from Low / Non-PCS to High PCS
4
   0.9%
3
   0.7%
Neutrophils - change from High/Non-PCS to Low PCS
15
   3.6%
12
   2.9%
Platelets - change from High / Non-PCS to Low PCS
4
   0.9%
7
   1.7%
Platelets - change from Low / Non-PCS to High PCS
2
   0.5%
6
   1.4%
5.Secondary Outcome
Title Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Hide Description

Shifts are presented as Baseline finding / Worse finding at anytime during the study.

Categories for findings are:

  • normal
  • abnormal, not clinically significant (Not CS)
  • abnormal, clinically significant (CS)
Time Frame Day 1 up to 7.64 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with both a baseline and a post-baseline ECG.
Arm/Group Title Early Laquinimod Switch From Placebo
Hide Arm/Group Description:

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Overall Number of Participants Analyzed 420 412
Measure Type: Count of Participants
Unit of Measure: Participants
Normal / Normal
189
  45.0%
198
  48.1%
Normal / Abnormal, Not CS
145
  34.5%
126
  30.6%
Normal / Abnormal, CS
2
   0.5%
3
   0.7%
Abnormal, Not CS / Normal
12
   2.9%
14
   3.4%
Abnormal, Not CS / Abnormal, Not CS
70
  16.7%
67
  16.3%
Abnormal, Not CS / Abnormal, CS
2
   0.5%
4
   1.0%
Abnormal, CS / Normal
0
   0.0%
0
   0.0%
Abnormal, CS / Abnormal, Not CS
0
   0.0%
0
   0.0%
Abnormal, CS / Abnormal, CS
0
   0.0%
0
   0.0%
Time Frame Day 1 up to 7.64 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early Laquinimod 0.6 mg Switch From Placebo to Laquinimod 0.6 mg
Hide Arm/Group Description

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.

The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

All-Cause Mortality
Early Laquinimod 0.6 mg Switch From Placebo to Laquinimod 0.6 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/423 (0.71%)      3/416 (0.72%)    
Show Serious Adverse Events Hide Serious Adverse Events
Early Laquinimod 0.6 mg Switch From Placebo to Laquinimod 0.6 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   108/423 (25.53%)      92/416 (22.12%)    
Blood and lymphatic system disorders     
Anaemia  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Bone marrow oedema  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Lymphadenitis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Cardiac disorders     
Acute coronary syndrome  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Acute myocardial infarction  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Angina pectoris  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Angina unstable  1  1/423 (0.24%)  1 2/416 (0.48%)  2
Atrial fibrillation  1  2/423 (0.47%)  2 0/416 (0.00%)  0
Cardiac failure chronic  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Cardiac failure congestive  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Coronary artery stenosis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Mitral valve incompetence  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Myocardial infarction  1  2/423 (0.47%)  2 2/416 (0.48%)  2
Myocardial ischaemia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Pericarditis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Silent myocardial infarction  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Ventricular extrasystoles  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Ventricular tachycardia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Ear and labyrinth disorders     
Deafness  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Vertigo  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Endocrine disorders     
Goitre  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hyperparathyroidism primary  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Parathyroid gland enlargement  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Eye disorders     
Blindness unilateral  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Eye haemorrhage  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Uveitis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Gastrointestinal disorders     
Abdominal adhesions  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Abdominal hernia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Abdominal pain  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Abdominal pain upper  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Constipation  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Diarrhoea  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Dysphagia  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Gastric ulcer  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Gastritis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Gastrooesophageal reflux disease  1  0/423 (0.00%)  0 2/416 (0.48%)  2
Hiatus hernia  1  2/423 (0.47%)  2 0/416 (0.00%)  0
Ileus  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Inguinal hernia  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Intestinal obstruction  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Irritable bowel syndrome  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Omental infarction  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Pancreatitis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Pancreatitis chronic  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Small intestinal obstruction  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Volvulus  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Vomiting  1  0/423 (0.00%)  0 1/416 (0.24%)  1
General disorders     
Asthenia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Chest discomfort  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Chest pain  1  2/423 (0.47%)  2 0/416 (0.00%)  0
Death  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Drowning  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Fatigue  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Gait disturbance  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Impaired healing  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Inflammation  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Influenza like illness  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Medical device pain  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Non-cardiac chest pain  1  0/423 (0.00%)  0 1/416 (0.24%)  2
Pyrexia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Systemic inflammatory response syndrome  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hepatobiliary disorders     
Autoimmune hepatitis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Biliary colic  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Cholecystitis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Cholecystitis acute  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Cholelithiasis  1  2/423 (0.47%)  2 1/416 (0.24%)  1
Cholestasis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Hepatitis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hepatotoxicity  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Hydrocholecystis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Infections and infestations     
Abdominal abscess  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Abscess limb  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Acute sinusitis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Appendicitis  1  4/423 (0.95%)  4 3/416 (0.72%)  3
Appendicitis perforated  1  2/423 (0.47%)  2 1/416 (0.24%)  1
Bartholin's abscess  1  1/423 (0.24%)  2 0/416 (0.00%)  0
Breast abscess  1  1/423 (0.24%)  2 0/416 (0.00%)  0
Cellulitis  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Cholecystitis infective  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Chronic tonsillitis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Cytomegalovirus infection  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Diverticulitis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Escherichia urinary tract infection  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Furuncle  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Groin abscess  1  2/423 (0.47%)  2 0/416 (0.00%)  0
Hepatic echinococciasis  1  0/423 (0.00%)  0 1/416 (0.24%)  2
Influenza  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Latent syphilis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Latent tuberculosis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Meningitis viral  1  0/423 (0.00%)  0 1/416 (0.24%)  2
Mycotoxicosis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Nasopharyngitis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Otitis media chronic  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Ovarian abscess  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Peritonitis  1  4/423 (0.95%)  4 0/416 (0.00%)  0
Periumbilical abscess  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Pertussis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Pharyngeal abscess  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Pilonidal cyst  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Pneumonia  1  1/423 (0.24%)  1 3/416 (0.72%)  4
Postoperative wound infection  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Pyelonephritis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Pyelonephritis acute  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Pyelonephritis chronic  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Salpingo-oophoritis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Staphylococcal infection  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Subcutaneous abscess  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Tonsillitis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Tubo-ovarian abscess  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Urinary tract infection  1  2/423 (0.47%)  2 1/416 (0.24%)  1
Urosepsis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Vestibular neuronitis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Injury, poisoning and procedural complications     
Accidental overdose  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Ankle fracture  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Brain contusion  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Comminuted fracture  1  0/423 (0.00%)  0 1/416 (0.24%)  2
Facial bones fracture  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Fall  1  6/423 (1.42%)  6 0/416 (0.00%)  0
Femur fracture  1  2/423 (0.47%)  2 0/416 (0.00%)  0
Foot fracture  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hip fracture  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Humerus fracture  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Joint dislocation  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Lower limb fracture  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Meniscus injury  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Postoperative wound complication  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Procedural complication  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Radius fracture  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Road traffic accident  1  0/423 (0.00%)  0 2/416 (0.48%)  2
Seroma  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Skull fracture  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Tendon rupture  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Tibia fracture  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Investigations     
C-reactive protein increased  1  4/423 (0.95%)  4 1/416 (0.24%)  1
Gamma-glutamyltransferase increased  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Hepatic enzyme increased  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hypercalcaemia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hypokalaemia  1  1/423 (0.24%)  2 0/416 (0.00%)  0
Obesity  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Arthritis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Back pain  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Bone pain  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Bursitis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Cervical spinal stenosis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Groin pain  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Intervertebral disc protrusion  1  2/423 (0.47%)  3 3/416 (0.72%)  3
Intervertebral disc space narrowing  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Joint hyperextension  1  1/423 (0.24%)  2 0/416 (0.00%)  0
Joint instability  1  2/423 (0.47%)  2 0/416 (0.00%)  0
Knee impingement syndrome  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Lumbar spinal stenosis  1  0/423 (0.00%)  0 2/416 (0.48%)  2
Neck pain  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Osteoarthritis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Osteochondrosis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Osteonecrosis  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Pseudarthrosis  1  1/423 (0.24%)  2 1/416 (0.24%)  1
Rheumatoid arthritis  1  1/423 (0.24%)  3 0/416 (0.00%)  0
Rotator cuff syndrome  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Spinal pain  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Spondylolisthesis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Tendon calcification  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  1/423 (0.24%)  1 0/416 (0.00%)  0
B-cell lymphoma  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Basal cell carcinoma  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Benign neoplasm of thyroid gland  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Benign ovarian tumour  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Breast cancer  1  2/423 (0.47%)  2 1/416 (0.24%)  1
Breast cancer stage II  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Cervix carcinoma stage 0  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Chronic lymphocytic leukaemia stage 1  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Fibroadenoma of breast  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hodgkin's disease  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Intraductal proliferative breast lesion  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Invasive breast carcinoma  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Invasive ductal breast carcinoma  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Keratoacanthoma  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Langerhans' cell histiocytosis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Lung adenocarcinoma metastatic  1  1/423 (0.24%)  2 0/416 (0.00%)  0
Metastases to central nervous system  1  1/423 (0.24%)  2 0/416 (0.00%)  0
Metastases to lung  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Oncocytoma  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Ovarian adenoma  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Ovarian cancer metastatic  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Papillary thyroid cancer  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Renal cancer  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Small cell lung cancer metastatic  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Squamous cell carcinoma of skin  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Tubular breast carcinoma  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Uterine leiomyoma  1  3/423 (0.71%)  3 4/416 (0.96%)  4
Vulval cancer  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Nervous system disorders     
Carotid artery stenosis  1  0/423 (0.00%)  0 1/416 (0.24%)  2
Carpal tunnel syndrome  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Cerebral artery occlusion  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Cerebral haemorrhage  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Cerebrovascular accident  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Cervicobrachial syndrome  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Epilepsy  1  3/423 (0.71%)  3 0/416 (0.00%)  0
Headache  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Hypoaesthesia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Ischaemic stroke  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Lethargy  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Lumbar radiculopathy  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Multiple sclerosis relapse  1  3/423 (0.71%)  3 2/416 (0.48%)  2
Optic neuritis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Paraesthesia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Sciatica  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Simple partial seizures  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Syncope  1  3/423 (0.71%)  3 1/416 (0.24%)  1
Transient ischaemic attack  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Trigeminal neuralgia  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/423 (0.24%)  1 3/416 (0.72%)  3
Psychiatric disorders     
Agoraphobia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Anxiety  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Completed suicide  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Depression  1  0/423 (0.00%)  0 2/416 (0.48%)  2
Mood disorder due to a general medical condition  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Neurosis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Panic disorder  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Substance-induced psychotic disorder  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Suicide attempt  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Renal and urinary disorders     
Bladder dysfunction  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Calculus urinary  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Chronic kidney disease  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Haematuria  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hydronephrosis  1  0/423 (0.00%)  0 2/416 (0.48%)  2
Ketonuria  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Nephrolithiasis  1  2/423 (0.47%)  2 1/416 (0.24%)  1
Tubulointerstitial nephritis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Urethral meatus stenosis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Urethral stenosis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Urinary incontinence  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Urinary retention  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Reproductive system and breast disorders     
Acquired hydrocele  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Endometrial hyperplasia  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Endometriosis  1  1/423 (0.24%)  2 2/416 (0.48%)  2
Fibrocystic breast disease  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hydrosalpinx  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Menometrorrhagia  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Metrorrhagia  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Ovarian cyst  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Uterine polyp  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Uterine prolapse  1  0/423 (0.00%)  0 1/416 (0.24%)  2
Vaginal prolapse  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Bronchiectasis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Bronchitis chronic  1  0/423 (0.00%)  0 1/416 (0.24%)  2
Dyspnoea  1  2/423 (0.47%)  3 0/416 (0.00%)  0
Nasal polyps  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Nasal septum deviation  1  2/423 (0.47%)  2 0/416 (0.00%)  0
Pharyngeal polyp  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Pleural effusion  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Pleurisy  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Pneumothorax  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Pulmonary embolism  1  1/423 (0.24%)  1 1/416 (0.24%)  1
Skin and subcutaneous tissue disorders     
Hidradenitis  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Surgical and medical procedures     
Cholecystectomy  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Hysterectomy  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Intervertebral disc operation  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Knee arthroplasty  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Nephrectomy  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Spinal fusion surgery  1  1/423 (0.24%)  1 0/416 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Hypertension  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Hypertensive crisis  1  0/423 (0.00%)  0 2/416 (0.48%)  2
Hypotension  1  0/423 (0.00%)  0 1/416 (0.24%)  1
Peripheral artery stenosis  1  0/423 (0.00%)  0 1/416 (0.24%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Laquinimod 0.6 mg Switch From Placebo to Laquinimod 0.6 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   299/423 (70.69%)      300/416 (72.12%)    
Blood and lymphatic system disorders     
Anaemia  1  22/423 (5.20%)  25 16/416 (3.85%)  17
Gastrointestinal disorders     
Abdominal pain upper  1  19/423 (4.49%)  23 31/416 (7.45%)  39
Diarrhoea  1  24/423 (5.67%)  31 21/416 (5.05%)  23
Nausea  1  24/423 (5.67%)  27 26/416 (6.25%)  37
General disorders     
Fatigue  1  25/423 (5.91%)  30 31/416 (7.45%)  38
Infections and infestations     
Bronchitis  1  33/423 (7.80%)  44 33/416 (7.93%)  46
Influenza  1  28/423 (6.62%)  41 34/416 (8.17%)  46
Nasopharyngitis  1  106/423 (25.06%)  169 112/416 (26.92%)  210
Sinusitis  1  27/423 (6.38%)  36 28/416 (6.73%)  47
Upper respiratory tract infection  1  43/423 (10.17%)  69 41/416 (9.86%)  65
Urinary tract infection  1  55/423 (13.00%)  110 39/416 (9.38%)  76
Injury, poisoning and procedural complications     
Fall  1  20/423 (4.73%)  30 23/416 (5.53%)  30
Investigations     
Alanine aminotransferase increased  1  13/423 (3.07%)  16 22/416 (5.29%)  27
C-reactive protein increased  1  26/423 (6.15%)  31 31/416 (7.45%)  37
Gamma-glutamyltransferase increased  1  22/423 (5.20%)  27 16/416 (3.85%)  23
Musculoskeletal and connective tissue disorders     
Arthralgia  1  41/423 (9.69%)  57 47/416 (11.30%)  59
Back pain  1  78/423 (18.44%)  127 77/416 (18.51%)  124
Musculoskeletal pain  1  11/423 (2.60%)  15 25/416 (6.01%)  29
Pain in extremity  1  28/423 (6.62%)  35 33/416 (7.93%)  45
Nervous system disorders     
Headache  1  57/423 (13.48%)  132 86/416 (20.67%)  160
Multiple sclerosis relapse  1  17/423 (4.02%)  35 29/416 (6.97%)  36
Psychiatric disorders     
Depression  1  35/423 (8.27%)  41 28/416 (6.73%)  35
Respiratory, thoracic and mediastinal disorders     
Cough  1  24/423 (5.67%)  26 35/416 (8.41%)  40
Vascular disorders     
Hypertension  1  32/423 (7.57%)  32 26/416 (6.25%)  26
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Pharmaceutical Industries, Ltd
Phone: 1-888-483-8279
EMail: USMedInfo@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
ClinicalTrials.gov Identifier: NCT00988052     History of Changes
Other Study ID Numbers: MS-LAQ-301E
2009-012989-30 ( EudraCT Number )
First Submitted: September 28, 2009
First Posted: October 1, 2009
Results First Submitted: November 28, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019